Study Evaluating the Effect of Isonatremic Dialysis Treatment in Chronic Kidney Disease Patients on Dialysis

Chronic Kidney Diseases Clinical Trial

— DISON-IRC  

Official title:

Evaluation of the Effect of Isonatremic (vs Conventional) Dialysis Treatment on the Control of Interdialytic Weight Gain in Chronic Kidney Disease Patients on Dialysis (Stage 5D)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04809493
• Other study ID #: RECHMPL20_0659
• Status: Recruiting
• Start date: March 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2022
• Source: University Hospital, Montpellier
• Contact: Jean-Paul CRISTOL, Prof
• Phone: +33(0)4 67 33 83 15
• Email: jp-cristol[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Aim of this study is to evaluate, in a population of chronic kidney disease patients on dialysis (Stage 5D), the effect of treatment with isonatremic dialysis (vs conventional dialysis), during an observational period of 2 months each, on:

• control of interdialytic weight gain

• perdialytic tolerance in terms of adverse events occurring during all of the sessions of the study

• body composition and thirst measured monthly during the 4 months of follow-up.

• tolerance to treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Chronic Kidney Disease patient on dialysis (stage 5D)

• With plasma sodium concentration between 130 and 140 mmol/L

• Anuric

• Patient dialysed with dialysis machine allowing isonatremic dialysis treatment

Exclusion criteria:

• Patient with plasma sodium concentration below 130 or above 140 mmol/

• Pacemaker

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Procedure:
• Conventional dialysis treatment
Conventional dialysis treatment
• Isonatremic dialysis treatment
Isonatremic dialysis treatment

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of interdialytic weight gain during treatment	change of interdialytic weight gain during treatment with isonatremic dialysis vs conventional dialysis during an observational period of 2 months each one.	1, 2, 3 and 4 months after inclusion
Secondary	Perdialytic tolerance in terms of adverse events occurring	Perdialytic tolerance in terms of adverse events occurring during all sessions of the study with isonatremic dialysis vs conventional dialysis for an observational period of 2 months each one.	1, 2, 3 and 4 months after inclusion
Secondary	Body composition	Body composition monthly during treatment with isonatremic dialysis vs conventional dialysis during an observational period of 2 months each one.	1, 2, 3 and 4 months after inclusion
Secondary	Rate of Tolerance	Rate of Tolerance during treatment with isonatremic dialysis vs conventional dialysis during an observational period of 2 months each one.	1, 2, 3 and 4 months after inclusion